Operating Handle For Selective Deflection Or Rotation Of A Catheter

ABSTRACT

A delivery device 100 includes a catheter assembly 120 and an operating handle 130. The operating handle 130 may include a nose 131 affixed to the catheter assembly 120, an axial shaft 180, a base 132 translationally fixed to a proximal end of the axial shaft, a screw 160 having external threads and a non-circular lumen 161, the axial shaft extending through the non-circular lumen, a proximal end 171 of a pull wire 170 being affixed to the screw, a knob 150 having internal threads engaged with the external threads of the screw, and a collar 140 extending at least partially around the axial shaft. When the collar 140 is in a proximal position, rotation of the knob 150 may deflect the distal end 121 of the catheter assembly 120. When the collar is in a distal position, rotation of the knob 150 may rotate the catheter assembly 120.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a divisional of U.S. patent application Ser. No.16/720,407, filed Dec. 19, 2019, which claims the benefit of the filingdate of U.S. Provisional Patent Application No. 62/785,970, filed onDec. 28, 2018, the disclosures of which are hereby incorporated hereinby reference.

BACKGROUND OF THE INVENTION

The present invention is related to implantable medical devices and,more particularly, to systems and methods for implanting a medicaldevice.

Numerous medical devices exist today, including but not limited toimplantable pacemakers, implantable cardioverter-defibrillators(“ICDs”), and the like. Medical devices of this type that areimplantable (hereinafter, generally “implantable medical devices” or“IMDs”) are configured to be implanted within the patient anatomy andcommonly employ one or more leads with electrodes that either receive ordeliver voltage, current or other electromagnetic pulses (generally“energy”) from or to an organ and/or tissue for diagnostic and/ortherapeutic purposes.

Typically, an intra-cardiac IMD or a lead coupled to an IMD isintroduced into the heart through a catheter-based delivery device. Ingeneral, the IMD may be connected to the delivery device in a dockedstate in which the IMD is securely attached to a catheter of thedelivery device. In the docked state, the delivery device may beoperated to guide the IMD to an implant site. Once the IMD is proximateto the implant site, the delivery device may be used to torque the IMDinto patient tissue.

Once the IMD is secured in patient tissue, the IMD may be moved into atethered state with respect to the delivery device. In the tetheredstate, the IMD is deployed from the delivery device, but remainsconnected thereto. In one known system and method, two separate anddistinct tethers connect the IMD to the catheter of the delivery devicein the tethered state. An implanting physician may test the IMD in thetethered state to make sure that the IMD is securely and electricallyconnected to patient tissue at a desired location. If the physicaland/or electrical connection between the IMD and the patient tissue isless than optimal, the IMD may be re-docked to the catheter of thedelivery device so that the IMD may be moved to a better implantedposition.

Once the implanting physician is satisfied with the location of the IMDwithin the patient anatomy, the IMD is transitioned from the tetheredstate to a released state. In the released state, the IMD isdisconnected from the catheter of the delivery device.

Despite the various improvements that have been made to delivery systemsfor IMD leads, conventional systems suffer from some shortcomings. AnIMD lead may rely on a helical, screw-in anchoring system that is usedto affix the IMD lead to target tissue, such as the inside of the heartwall. During the implantation procedure, an implanting physician mayneed to deflect and/or rotate the distal end of the catheter of thedelivery device so that the IMD lead can be affixed to the desiredlocation. It may be difficult to accurately rotate the catheter of aconventional delivery device to place the IMD lead at the desiredlocation and rotational orientation, which may result in inadvertenttranslation of the distal end of the catheter.

There therefore is a need for further improvements to the devices,systems, and methods for transcatheter delivery of IMD leads, and inparticular, for transcatheter delivery of pacemaker leads. Among otheradvantages, the present invention may address one or more of theseneeds.

BRIEF SUMMARY OF THE INVENTION

The disclosure herein describes multiple embodiments of a deliverydevice for an implantable medical device. The delivery device mayinclude a catheter assembly having a proximal end, a distal end, and acompartment at the distal end for retaining the implantable medicaldevice. The catheter assembly may extend along a first longitudinalaxis. The catheter assembly may have a pull wire extending therethrough.A distal end of the pull wire may be affixed to the distal end of thecatheter assembly. The delivery device may include an operating handleextending along a second longitudinal axis.

The operating handle may include a nose affixed to a proximal end of thecatheter assembly, an axial shaft having a distal end affixed to thenose and a proximal end, a base translationally fixed to the proximalend of the axial shaft, a screw having external threads and anon-circular lumen, a knob having internal threads engaged with theexternal threads of the screw, the knob being translationally fixed tothe nose, and a collar extending at least partially around the axialshaft in a circumferential direction. The axial shaft may extend alongthe second longitudinal axis. The axial shaft may extend through thenon-circular lumen so that the screw is translatable along the axialshaft and nonrotatable relative to the axial shaft. A proximal end ofthe pull wire may be affixed to the screw.

The collar may be rotationally fixed to the nose, the axial shaft, andthe screw. The collar may be translatable between a proximal positionand a distal position. With the collar in the proximal position, theknob may be rotatable relative to the collar and the collar may benonrotatable relative to the base, so that rotation of the knob aboutthe second longitudinal axis results in deflection of the distal end ofthe catheter assembly away from the first longitudinal axis. With thecollar in the distal position, the base may be rotatable relative to thecollar and the collar may be nonrotatable relative to the knob, so thatrotation of the knob about the second longitudinal axis results inrotation of the catheter assembly about the second longitudinal axis.

Also described herein are multiple embodiments of an operating handleconfigured to be coupled to a catheter assembly. The operating handlemay include a nose configured to be affixed to a proximal end of thecatheter assembly, an axial shaft having a distal end affixed to thenose, a proximal end, and a longitudinal axis, a base translationallyfixed to the proximal end of the axial shaft, a screw having externalthreads and a non-circular lumen, a knob having internal threads engagedwith the external threads of the screw, and a collar extending at leastpartially around the axial shaft in a circumferential direction. Theaxial shaft may extend through the non-circular lumen so that the screwis translatable along the axial shaft and nonrotatable relative to theaxial shaft. The knob may be translationally fixed to the nose.

The collar may be rotationally fixed to the nose, the axial shaft, andthe screw. The collar may be translatable between a proximal positionand a distal position. With the collar in the proximal position, theknob may be rotatable relative to the collar and the collar may benonrotatable relative to the base, so that rotation of the knob aboutthe longitudinal axis results in translation of the screw along theaxial shaft. With the collar in the distal position, the base may berotatable relative to the collar and the collar may be nonrotatablerelative to the knob, so that rotation of the knob about thelongitudinal axis results in rotation of the nose, the axial shaft, thescrew, and the collar relative to the base.

Further described herein are multiple embodiments of a method of movinga catheter assembly with an operating handle. The method may includeproviding the catheter assembly and the operating handle. The operatinghandle may have a nose affixed to a proximal end of the catheterassembly, an axial shaft having a distal end affixed to the nose, a basetranslationally fixed to a proximal end of the axial shaft, a screwhaving external threads and a non-circular lumen, the axial shaftextending through the non-circular lumen, a pull wire extending from thescrew to a distal end of the catheter assembly, a knob having internalthreads engaged with the external threads of the screw, and a collarextending at least partially around the axial shaft in a circumferentialdirection.

The method may include moving the collar to a distal position relativeto the base. The method may include, while the collar is in the distalposition, rotating the knob in a first direction to rotate the catheterassembly, the nose, the axial shaft, the screw, and the collar relativeto the base. The method may include moving the collar to a proximalposition. The method may include, while the collar is in the proximalposition, rotating the knob in the first direction to pull the pull wirein a proximal direction, thereby deflecting the distal end of thecatheter assembly away from a longitudinal axis of the catheterassembly.

BRIEF DESCRIPTION OF THE DRAWINGS

Various embodiments of the present invention will now be described withreference to the appended drawings. It is to be appreciated that thesedrawings depict only some embodiments of the invention and are thereforenot to be considered limiting of its scope.

FIG. 1A is a perspective view of an operating handle of a conventionaldelivery device for delivering a lead for an implantable medical device(IMD) into a patient;

FIG. 1B is an end view of the operating handle of FIG. 1A;

FIG. 2A is a perspective view of a delivery device for delivering an IMDlead into a patient, shown with the catheter assembly in a straightposition;

FIG. 2B is a perspective view of the delivery device of FIG. 2A, shownwith the catheter assembly in a deflected position;

FIG. 2C is an exploded perspective view of the operating handle of thedelivery device of FIG. 2A;

FIG. 2D is a side view of the distal end of the catheter assembly of thedelivery device of FIG. 2A, shown with the distal portion of the IMDlead extending out of the catheter assembly;

FIG. 3A is a side view of the operating handle of the delivery device ofFIG. 2A, shown with the collar in a proximal position;

FIG. 3B is a longitudinal cross-section through a portion of theoperating handle of FIG. 3A;

FIG. 3C is another longitudinal cross-section through the operatinghandle of FIG. 3A, shown in a perspective view;

FIG. 4A is a side view of the operating handle of the delivery device ofFIG. 2A, shown with the collar in a distal position;

FIG. 4B is a longitudinal cross-section through a portion of theoperating handle of FIG. 4A; and

FIG. 4C is another longitudinal cross-section through a portion of theoperating handle of FIG. 4A, shown in a perspective view.

DETAILED DESCRIPTION

As used herein, the terms “proximal” and “distal” are to be taken asrelative to a user using the disclosed delivery devices. “Proximal” isto be understood as relatively close to the user and “distal” is to beunderstood as relatively farther away from the user. As used herein, theterms “generally,” “substantially,” “approximately,” and “about” areintended to mean that slight deviations from absolute are includedwithin the scope of the term so modified.

FIGS. 1A and 1B show an operating handle of a conventional deliverydevice 10 for manipulating a catheter assembly 20 in a patient. For someuses, such as installing an end of a pacemaker lead into cardiac tissue(or other cardiac catheter uses), it is necessary that a user have theability to deflect or steer the distal tip of the catheter assembly 20away from a longitudinal axis of the catheter assembly, and also torotate the distal tip about a longitudinal axis of the catheterassembly. When using the conventional delivery device 10, a user mayrotate the distal tip of the catheter assembly 20 about its longitudinalaxis by rotating the user's hand and wrist to rotate the entireoperating handle 30.

The hand and wrist rotation required to rotate the distal tip of thecatheter assembly 20 about its longitudinal axis may result inshortcomings of the conventional delivery device 10 that can reduce theaccuracy of or cause misuse of the device in a patient. As can be seenin FIG. 1B, rotating the user's hand and wrist may only permit a partialangular rotation A of the operating handle 30, since the wrist has alimited range of angular rotation. Also, a typical wrist rotation mayresult in the axis of rotation being misaligned with the longitudinalaxis of the operating handle 30, so that the operating handle istranslated and rotated during rotation of the wrist. If the operatinghandle 30 is translated during rotation, the distal tip of the catheterassembly 20 may also be translated within the patient, which may make itmore difficult to accurately place the distal tip of the catheterassembly at a desired location within the patient, and which may resultin unintended harmful contact between the distal tip of the catheterassembly and cardiac tissue.

Referring now to FIGS. 2A-2D to illustrate the structure and function ofthe present invention, an exemplary delivery device 100 for deliveringinto a patient an IMD lead 110 having a helical tip 112 has a catheterassembly 120 for delivering the IMD lead to and deploying the IMD leadat a target location. The helical tip 112 may be a helical, screw-inanchor that may be used to affix the IMD lead 110 to target tissue, suchas the inside of the heart wall. In one example, the IMD lead 110 may bean Abbott Tendril MRI STS 2088 pacing lead. The delivery device 100 alsoincludes an operating handle 130 for controlling deployment of the IMDlead 110 from the catheter assembly 120, for rotating the catheterassembly about a longitudinal axis of the catheter assembly (the firstlongitudinal axis L1), and for deflecting a distal end 121 of thecatheter assembly away from the first longitudinal axis.

The catheter assembly 120 is configured to removably retain a distalportion of the IMD lead 110 at its distal end 121. The catheter assembly120 includes an outer shaft 122 that is affixed at its proximal end toan insert 123 that is fixedly disposed inside the operating handle 130by interference between features of the insert and the handle, such thatthe outer shaft is fixedly coupled to the operating handle. Inparticular, there may be interference between external features of theinsert 123 and internal features of a nose 131 of the handle 130, whichwill be described below. The outer shaft 122 has a compartment thereinconfigured to receive the distal portion of the IMD lead 110. The distalportion of the IMD lead 110 may be exposed by being advanced out of theouter shaft 122 and may be covered by being retracted into the outershaft. The outer shaft 122 may be made of a flexible material such asnylon 11 or nylon 12, and it may have a round braid construction (i.e.,round cross-section fibers braided together) or flat braid construction(i.e., rectangular cross-section fibers braided together), for example.A guide wire, a proximal end of the IMD lead 110, and/or mapping wiresmay extend through a lumen of the outer shaft 122 and into the operatinghandle 130.

The distal end 121 of the catheter assembly 120 is movable between astraight position shown in FIG. 2A, a deflected position shown in FIG.2B, and any intermediate position between the straight position and thedeflected position. In the straight position, the distal end 121 of thecatheter assembly 120 is aligned with the longitudinal axis L1 of thecatheter assembly. In the deflected position, the distal end 121 of thecatheter assembly 120 can be deflected away from the longitudinal axisL1.

As shown in FIG. 2B, the distal end 121 of the catheter assembly 120 mayhave a “C” shape when disposed in the deflected position, in which abase segment 124 of the catheter assembly extends in a first directionD1 along the first longitudinal axis L1, a first segment 125 of thedistal end 121 extends in a second direction D2 perpendicular to thefirst longitudinal axis, and a second segment 126 of the distal endextends in a third direction D3 perpendicular to the second directionand parallel to but opposite the first direction. The catheter assembly120 may have a first weakened portion 127 disposed between the basesegment 124 and the first segment 125 of the distal end 121, and asecond weakened portion 128 disposed between the first segment and thesecond segment 126.

Although in the particular example shown in FIG. 2B, the seconddirection D2 is perpendicular to the first longitudinal axis L1, and thethird direction D3 is opposite the first direction D1, that need not bethe case. In other embodiments, the second and third directions D2 andD3 may have any angular orientation relative to one another and relativeto the first direction D1. In some examples, the number of segmentscomprising the distal end 121 of the catheter assembly 120 may be moreor less than the two segments shown in FIGS. 2A and 2B, and the segmentsmay have any length relative to one another. Although the distal end 121of the catheter assembly 120 is shown as having a “C” shape in thedeflected position, in other examples, the distal end may have any otherdeflected shape.

The first and second weakened portions 127, 128 may be less resistant tobending than the base segment 124, the first segment 125, and the secondsegment 126. The first and second weakened portions 127, 128 areconfigured to bend upon proximal retraction of a pull wire, which willbe described below. The first and second weakened portions 127, 128 arebiased towards the straight position shown in FIG. 2A, such that whentension on the pull wire is released, the first and second segments 125,126 will return to the straight position i.e., in collinear alignmentwith the base segment 124. In one example, the first and second weakenedportions 127, 128 may each include a memory metal therein that is biasedto a straight position.

The operating handle 130 is adapted to control the positioning of thedistal end 121 of the catheter assembly 120, so that the distal end ofan IMD lead 110 located in a compartment of the catheter assembly can beproperly positioned for deployment into cardiac tissue, for example. Theoperating handle 130 may be toggled between a catheter deflectionconfiguration, as shown in FIGS. 3A-3C, and a catheter rotationconfiguration, as shown in FIGS. 4A-4C. The operating handle 130 has acollar 140 that may be toggled proximally or distally to set theoperating handle in the catheter deflection configuration or thecatheter rotation configuration, respectively. A knob 150 of theoperating handle 130 may be rotated about a longitudinal axis of theoperating handle (the second longitudinal axis L2) to either deflect thedistal end 121 of the catheter assembly 120 away from the firstlongitudinal axis L1 by retracting a screw 160 coupled to a pull wire170, or to rotate the catheter assembly about the second longitudinalaxis, depending on whether the collar 140 is in its proximal or distalposition. The operating handle 130 may be configured to be operated by asingle hand of a user. In such an embodiment, the collar 140 and theknob 150 may each be configured to be moved by only the thumb and indexfinger of a single hand of a user.

Returning to FIGS. 2A-2D, the operating handle 130 includes a nose 131and a base 132. The nose 131 includes a left portion 131 a and a rightportion 131 b. The left and right portions 131 a and 131 b may beindividual pieces joined to one another as shown in FIG. 2A. The base132 includes a left portion 132 a and a right portion 132 b. The leftand right portions 132 a and 132 b may be individual pieces joined toone another as shown in FIG. 2A. Fasteners 133 may be used to join theleft and right portions 131 a, 131 b to one another, and to join theleft and right portions 132 a, 132 b to one another.

Referring to FIGS. 3A-3C, the collar 140 has a generally cylindricalshape and extends into a portion of an elongated space 136 within thebase 132 of the operating handle 130. The collar 140 has an annular ring141 defined on an outer surface 142 of the collar at the distal end ofthe collar. The ring 141 extends completely around the outer surface 142of the collar 140 with its central axis coextensive with the secondlongitudinal axis L2. The ring 141 has an outer diameter that is greaterthan an inner diameter of the base 132, such that interference betweenthe ring and a distal edge of the base prevents the ring from beingcompletely inserted into the base.

The collar 140 has a first set of serrations 143 defined in the outersurface 142 at the proximal end of the collar, a second set ofserrations 144 defined in an inner surface 145 of a reduced diameterportion at the proximal end of the collar, and a third set of serrations146 defined in the inner surface of the collar at the distal end of thecollar. The serrations 143 each extend adjacent to one another in adirection parallel to the second longitudinal axis L2 and completelyaround the outer surface 142. The serrations 144 each extend adjacent toone another in a direction parallel to the second longitudinal axis L2and completely around the inner surface 145. The serrations 146 eachextend adjacent to one another in a direction parallel to the secondlongitudinal axis L2 and completely around the inner surface 145.

The outer serrations 143 are configured to be selectively engageable ina mating configuration with corresponding serrations 134 defined in aninner surface of the handle base 132. The serrations 134 each extendadjacent to one another in a direction parallel to the secondlongitudinal axis L2 and completely around the inner surface of the base132. When the collar 140 is in the proximal position shown in FIGS.3A-3C, the outer serrations 143 are engaged with the inner serrations134, such that the collar is rotationally locked relative to the base132. When the collar 140 is moved to the proximal position, the range ofmotion of the collar along the second longitudinal axis is proximallylimited by interference between the collar and the base 132. When thecollar 140 is in the distal position shown in FIGS. 4A-4C, the outerserrations 143 are disengaged from the inner serrations 134, such thatthe collar may be rotated about the second longitudinal axis L2 relativeto the base 132. When the collar 140 is moved to the distal position,the range of motion of the collar along the second longitudinal axis isdistally limited by interference between the collar and the knob 150.

The knob 150 has a bulbous outer surface 151 that is configured to beeasily grasped by the thumb and forefinger of a user and rotated inorder to deflect the distal end 121 of the catheter assembly 120 in thecatheter deflection configuration (FIGS. 3A-3C), or in order to rotatethe catheter assembly and the handle nose 131 together in the catheterrotation configuration (FIGS. 4A-4C). The knob 150 is internallythreaded for engagement with corresponding external threads of the screw160, which will be described below. The knob 150 has a circumferentialgroove 152 defined in its outer surface 151 that is configured to engagea proximal flange 135 of the nose 131, so that the knob is constrainedfrom translating relative to the nose along the second longitudinal axisL2, but is permitted to rotate about the second longitudinal axisrelative to the nose unless the knob is rotationally locked relative tothe nose by other components, as will be described below.

The knob 150 has serrations 153 defined in the outer surface 151 at theproximal end of the knob. The serrations 153 each extend adjacent to oneanother in a direction parallel to the second longitudinal axis L2 andcompletely around the outer surface 151. The outer serrations 153 areconfigured to be selectively engageable in a mating configuration withthe inner serrations 146 at the distal end of the collar 140. When thecollar 140 is in the proximal position shown in FIGS. 3A-3C, the outerserrations 153 are disengaged from the inner serrations 146, such thatthe knob 150 may be rotated about the second longitudinal axis L2relative to the collar. When the collar 140 is in the distal positionshown in FIGS. 4A-4C, the outer serrations 153 are engaged with theinner serrations 146, such that the knob 150 is rotationally lockedrelative to the collar.

The left and right portions 131 a, 131 b of the handle nose 131 and theleft and right portions 132 a, 132 b of the handle base 132 collectivelydefine the elongated space 136 in the operating handle 130 in which thescrew 160 may travel. The elongated space 136 preferably permits thescrew 160 to travel a distance that is at least as long as theanticipated length that the pull wire 170 affixed to the distal end 121of the catheter assembly 120 needs to travel (e.g., about 12.7 mm orless), such that the distal end of the catheter assembly can be movedfrom the straight position to the fully deflected position. A series ofribs 137 in the left and right portions 131 a, 131 b of the nose 131 andthe inner surface 145 of the collar 140 collectively define an enlargedbore 138 that is sized to freely and slidingly receive the screw 160.The enlarged bore 138 has an inner diameter slightly larger than theouter diameter of the screw 160.

The screw 160 extends along the second longitudinal axis L2 and isconfigured to remain threadedly engaged with the knob 150 throughout itsrange of travel. The screw 160 preferably is longer than the anticipatedmaximum travel distance of the screw within the elongated space 136(e.g., at least about 25 mm), such that the screw does not fullydisengage from the knob 150 during movement of the distal end 121 of thecatheter assembly 120 between the straight position and the deflectedposition. The travel distance of the screw 160 within the elongatedspace 136 is limited in a distal direction by interference between thedistal end of the screw 160 and a proximal-facing surface of adistalmost one of the ribs 137. The travel distance of the screw 160 islimited in a proximal direction by interference between the proximal end165 of the screw 160 and a distal-facing surface of an axial shaft 180,which will be described below.

The screw 160 has a non-circular lumen 161 extending therethrough alongthe second longitudinal axis L2. The non-circular lumen 161 isconfigured to slidably receive the axial shaft 180 therethrough withminimal clearance. As shown in the figures, the non-circular lumen 161has a generally square cross-section, but this need not always be thecase. In other embodiments, the non-circular lumen 161 may have anycross-sectional shape that permits the axial shaft 180 to berotationally locked relative to the screw 160, such as any regular orirregular polygon that is configured to slidably receive the axial shaft180 therethrough with minimal clearance. As shown in the figures, thenon-circular lumen 161 extends along the second longitudinal axis L2,but this need not always be the case. In other embodiments, thenon-circular lumen 161 may have a central longitudinal axis that isoffset from and parallel to the second longitudinal axis L2.

The screw 160 has a slot 162 extending radially inward from the threadedouter surface of the screw in a direction parallel to the secondlongitudinal axis L2. The slot is configured to provide a pathway forthe pull wire 170 to extend into the screw 160, and a pathway for otherwires from the catheter assembly 120 (e.g., mapping wires, not shown) toextend into a lumen 181 of the axial shaft 180 and out of the operatinghandle 130 through a proximal opening 139 in the handle base 132. Theproximal end 171 of the pull wire 170 is affixed to the screw 160, sothat the proximal end of the pull wire and the screw may translateproximally or distally together relative to the axial shaft 180.

The proximal end 171 of the pull wire 170 extends through a bore 163that extends axially through the screw 160 between the slot 162 and arecess 164 extending into the proximal end 165 of the screw. Theproximal end 171 of the pull wire 170 is affixed to an insert 166 thatis removably engaged in the recess 164, so that the insert may beselectively affixed to the screw 160 for operative use, or removed fromthe screw so that the pull wire may be replaced. In the example shown inthe figures, the proximal end 171 of the pull wire 170 is removablyaffixed to the screw 160 via engagement of the insert 166 in the recess164, but that need not always be the case. In some embodiments, theproximal end of the pull wire may be directly affixed to the screw 160without use of a removable insert.

The pull wire 170 is configured to deflect the distal end 121 of thecatheter assembly 120 away from the first longitudinal axis L1 when theproximal end 171 of the pull wire is translated proximally. The pullwire 170 may be affixed to one side of a pull ring (not shown) that isdisposed at the distal end 121 of the catheter assembly 120. The distalend 121 of the catheter assembly 120 may be biased towards the straightposition shown in FIG. 2A, so when the proximal end 171 of the pull wire170 is translated distally, thereby removing tension in the pull wire,the bias of the distal end of the catheter assembly may move the distalend to the straight position. Further details regarding how a pull wiremay deflect a distal end of a catheter assembly may be found in U.S.Pat. No. 7,706,891, which is hereby incorporated by reference herein inits entirety.

The axial shaft 180 is configured to translationally fix the nose 131and the base 132 of the handle 130 to one another while selectivelypermitting or preventing the nose from rotating relative to the base,depending on the position of the collar 140. The axial shaft 180 istranslationally fixed to the nose 131 by the engagement of ribs 182 a,182 b (FIG. 2C) formed in the left and right portions 131 a, 131 b ofthe nose with corresponding vertical slots 183 a, 183 b in side surfacesof the axial shaft. The axial shaft 180 is rotationally locked to thenose 131 by the engagement of the corresponding non-circularcross-sectional shapes of the distal end of the axial shaft and the ribsof the nose with minimal clearance therebetween.

The axial shaft 180 is translationally fixed to the base 132 byinterference between distal and proximal ribs 184 a, 184 b (FIG. 2C)formed in the left and right portions 132 a, 132 b of the base andcorresponding distal and proximal flanges 185 a, 185 b disposed at theproximal end of the axial shaft. The distance between the distal andproximal ribs 184 a, 184 b is slightly greater than the distance betweenthe distal and proximal flanges 185 a, 185 b, such that interferencebetween the distal rib and the distal flange prevents distal translationof the axial shaft 180 relative to the base 132, and interferencebetween the proximal rib and the proximal flange prevents proximaltranslation of the axial shaft relative to the base.

An intermediate portion of the axial shaft 180 has an enlargedcylindrical disk 187 with serrations 186 formed around its outersurface. The serrations 186 each extend adjacent to one another in adirection parallel to the second longitudinal axis L2 and completelyaround the outer surface of the disk 187. The outer serrations 186 areconfigured to be permanently engaged in a mating configuration with theinner serrations 144 at the proximal end of the collar 140, regardlessof the position of the collar. For example, when the collar 140 is inthe proximal position of FIG. 3B, the inner serrations 144 at theproximal end of the collar are engaged with a proximal portion of theouter serrations 186, and when the collar is in the distal position ofFIG. 4B, the inner serrations at the proximal end of the collar areengaged with a distal portion of the outer serrations of the disk 187.

As shown in the figures, the distal end of the axial shaft 180 has agenerally square cross-section that corresponds to the shape of thelumen 161 extending through the screw 160. However, this need not alwaysbe the case. In other embodiments, the distal end of the axial shaft 180may have any cross-sectional shape that permits the shaft to berotationally locked relative to the screw 160, such as any regular orirregular polygon that is configured to be received within thenon-circular lumen 161 with minimal clearance. As shown in the figures,the distal end of the axial shaft 180 extends along the secondlongitudinal axis L2, but this need not always be the case. In otherembodiments, the distal end of the axial shaft 180 may have a centrallongitudinal axis that is offset from and parallel to the secondlongitudinal axis L2.

In operation, a user may selectively toggle the collar 140 between theproximal position of FIGS. 3A-3C, in which the knob 150 has freedom ofrotation relative to all other components of the operating handle 130while the screw 160 is at intermediate locations between the distal andproximal ends of its travel range, and the distal position of FIGS.4A-4C, in which the knob is rotationally locked to all other componentsof the operating handle except for the base 132 of the handle. While thedistal end 121 of the catheter assembly 120 is disposed in a patient,the user may freely toggle the collar 140 back and forth between theproximal and distal positions, depending on whether the user desires todeflect or straighten the distal end of the catheter assembly, orwhether the user desires to rotate the catheter assembly about thesecond longitudinal axis L2 in order to change the direction ofdeflection of the distal end of the catheter assembly.

When the collar 140 is in the proximal position of FIGS. 3A-3C, theoperating handle 130 is set in the catheter deflection configuration.Before insertion of the distal end 121 of the catheter assembly 120 intoa patient, the catheter assembly will be in the straight position shownin FIG. 2A, and the screw 160 will be in its distalmost position. Inthis condition, the pull wire 170 will be in its distalmost position inwhich it does not exert any tension on the distal end 121 of thecatheter assembly 120 to deflect same. If it is desired to deflect thedistal end 121 of the catheter assembly 120 away from the firstlongitudinal axis L1, the user may grasp the knob 150 and rotate itclockwise from the perspective of the proximal end of the operatinghandle 130. In other embodiments, the thread orientation may be reversedso that the knob may be rotated counterclockwise to deflect the distalend 121 of the catheter assembly 120.

Due to the engagement of the threads of the knob 150 with the threads ofthe screw 160, the clockwise rotation of the knob will result in thescrew being translated proximally along the axial shaft 180. Since theproximal end 171 of the pull wire 170 is affixed to the screw 160,proximal translation of the screw will proximally translate the pullwire, thereby beginning deflection of the distal end 121 of the catheterassembly 120.

While the knob 150 is rotating, the screw 160 will translate along theaxial shaft 180 because the other components of the operating handle 130are all rotationally locked to the axial shaft. In particular, the screw160 is rotationally locked to the axial shaft 180 due to the engagementof the non-circular axial shaft into the non-circular lumen 161 of thescrew, and the nose 131 is rotationally and translationally locked tothe distal end of the axial shaft 180. The axial shaft 180 istranslationally locked to the base 132 of the handle 130 due to theengagement of the flanges 185 a, 185 b of the axial shaft between theribs 184 a, 184 b of the base. The axial shaft 180 is rotationallylocked to the collar 140 due to the engagement of the outer serrations186 of the disk 187 with the inner serrations 144 of the collar, and thecollar is rotationally locked to the base 132 due to the engagement ofthe outer serrations 143 of the collar with the inner serrations 134 ofthe base.

The user may continue to rotate the knob 150 clockwise until the distalend 121 of the catheter assembly 120 is deflected to the desiredposition. To return the distal end 121 of the catheter assembly 120 tothe straight position, the user may rotate the knob 150counterclockwise, thereby advancing the screw 160 and the pull wire 170distally along the axial shaft 180. As the pull wire 170 advancesdistally, it will tend to slacken, and the bias of the distal end 121 ofthe catheter assembly 120 will reduce the degree of deflection of thedistal end to the degree permitted by the slackening of the pull wire.When the screw 160 is fully advanced to its distalmost position, thepull wire 170 will slacken sufficiently for the bias of the distal end121 of the catheter assembly 120 to fully return the distal end of thecatheter assembly to the straight position.

When the collar 140 is in the distal position of FIGS. 4A-4C, theoperating handle 130 is set in the catheter rotation configuration.Before insertion of the distal end 121 of the catheter assembly 120 intoa patient, the nose 131 of the operating handle 130 will be in aninitial rotational orientation relative to the base 132, which may bethe rotational orientation shown in FIG. 4A or any other rotationalorientation.

If it is desired to rotate the catheter assembly 120 about the secondlongitudinal axis L2, the user may grasp the knob 150 and rotate itclockwise or counterclockwise, depending on which rotational orientationof the catheter assembly is desired. Due to the knob 150 beingrotationally locked to all of the components except for the base 132,rotation of the knob will result in the catheter assembly 120, the nose131, the screw 160, the axial shaft 180, and the collar 140 beingrotated together about the second longitudinal axis L2 relative to thebase. In particular, the knob 150 is rotationally locked to the collar140 due to engagement between the outer serrations 153 of the knob andthe inner serrations 146 of the collar. The collar 140 is rotationallylocked to the axial shaft 180 due to the engagement of the innerserrations 144 of the collar with the outer serrations 186 of the disk187. The axial shaft 180 is rotationally locked to the nose 131 and thescrew 160 due to the non-circular axial shaft being received in a distalportion of the nose with minimal clearance, and being received throughthe non-circular lumen 161 of the screw with minimal clearance. The knob150 is not rotationally locked to the base 132 since the outerserrations 143 of the collar 140 are not engaged with the innerserrations 134 of the base.

Although the longitudinal axis L1 of the catheter assembly 120 islaterally offset from the second longitudinal axis L2, the small amountof the offset relative to the length of the catheter assembly willlikely result in only a small amount of longitudinal translation of thecatheter assembly as it is rotated about the second longitudinal axis,compared to the larger longitudinal translation that may result whenrotating the catheter assembly 20 of FIG. 1A. Once the user is satisfiedwith the rotational orientation of the catheter assembly 120, the usermay slide the collar 140 to the proximal position of FIGS. 3A-3C,thereby rotationally decoupling the knob 150 from the nose 131, whichmay prevent the user from unintentionally changing the rotationalorientation of the nose relative to the base 132.

Compared to the conventional delivery device 10, the delivery device 100may permit a user to execute fine rotation of the catheter assembly 120about the second longitudinal axis L2 while more easily maintaining handposition on the operating handle 130, thereby minimizing longitudinaltranslation of the catheter assembly during such fine rotation. Incontrast, a user may not be able to use his or her wrist to rotate theconventional delivery deice 10 a full 360 degrees without changing howhe or she is gripping the operating handle 30. Therefore, if a user ofthe conventional delivery device 10 needs to change hand grip whilerotating the operating handle 30, this may result in significantunintended longitudinal translation of the catheter assembly 20 that maybe greater than the minimal longitudinal translation of the catheterassembly 120 during rotation of the nose 131 of the operating handle130.

Although the embodiments herein have been described as being configuredto deliver a distal end of an IMD lead 110, such as a pacing lead, anyof the operating handles and methods described herein may beincorporated into any other type of medical device where fine control ofdeflection and rotation of the distal end of a catheter is desired. Forexample, the devices described herein can be modified to deliver anyprosthetic device into a patient in a compartment that is covered by adistal sheath similar to those described herein. In some embodiments,the implantable medical device may be a leadless device entirelycontained within the distal end 121 of the catheter assembly 120 beforedeployment into a patient. In other examples, the devices describedherein can be configured to deliver an expandable heart valve such as aprosthetic aortic valve or a prosthetic mitral valve to a targetlocation in a patient. Such a prosthetic heart valve may be radiallycompressed and contained within the distal end 121 of the catheterassembly 120, and the prosthetic heart valve may be deflected androtated for placement at a desired location, such as a native aortic ormitral valve annulus.

In particular embodiments, the operating handles described herein can beconfigured to manipulate other types of catheters, so that deflectionand rotation of the distal end of the catheter may be finely controlled.In one example, the operating handles described herein may be configuredto manipulate the distal end of an ablation catheter, so that energy maybe delivered to anatomical structures (e.g., tissue to be ablated) atdesired locations within a patent. In another example, the operatinghandles described herein may be configured to manipulate the distal endof a mapping catheter, so that desired locations within anatomicalstructures (e.g., arteries, veins, organs, etc.) within a patent may beimaged.

Although the serrations 134, 143, 144, 146, 153, and 186 are describedherein as each extending adjacent to one another in a direction parallelto the second longitudinal axis L2 and completely around the secondlongitudinal axis, that need not always be the case. Any or all of thepairs of serrations 134/143, 146/153, and 144/186 may have anycomplimentary shape with one another, so long as they permit the twoengaged components to translate relative to one another while beingrotationally locked relative to one another when engaged. For example,any of the pairs of serrated components may each contain only a fewcomplimentary teeth spaced apart about the second longitudinal axis L2,or any of the pairs of serrated components may have their serrationsreplaced with one or more pins configured to engage with one or morecomplimentary recesses having any spacing about the second longitudinalaxis.

Although the invention herein has been described with reference toparticular embodiments, it is to be understood that these embodimentsare merely illustrative of the principles and applications of thepresent invention. It is therefore to be understood that numerousmodifications may be made to the illustrative embodiments and that otherarrangements may be devised without departing from the spirit and scopeof the present invention as defined by the appended claims.

It will be appreciated that the various dependent claims and thefeatures set forth therein can be combined in different ways thanpresented in the initial claims. It will also be appreciated that thefeatures described in connection with individual embodiments may beshared with others of the described embodiments.

In summary, the disclosure herein describes multiple embodiments of adelivery device for an implantable medical device. The delivery devicemay include a catheter assembly having a proximal end, a distal end, anda compartment at the distal end for retaining the implantable medicaldevice. The catheter assembly may extend along a first longitudinalaxis. The catheter assembly may have a pull wire extending therethrough.A distal end of the pull wire may be affixed to the distal end of thecatheter assembly. The delivery device may include an operating handleextending along a second longitudinal axis.

The operating handle may include a nose affixed to a proximal end of thecatheter assembly, an axial shaft having a distal end affixed to thenose and a proximal end, a base translationally fixed to the proximalend of the axial shaft, a screw having external threads and anon-circular lumen, a knob having internal threads engaged with theexternal threads of the screw, the knob being translationally fixed tothe nose, and a collar extending at least partially around the axialshaft in a circumferential direction. The axial shaft may extend alongthe second longitudinal axis. The axial shaft may extend through thenon-circular lumen so that the screw is translatable along the axialshaft and nonrotatable relative to the axial shaft. A proximal end ofthe pull wire may be affixed to the screw.

The collar may be rotationally fixed to the nose, the axial shaft, andthe screw. The collar may be translatable between a proximal positionand a distal position. With the collar in the proximal position, theknob may be rotatable relative to the collar and the collar may benonrotatable relative to the base, so that rotation of the knob aboutthe second longitudinal axis results in deflection of the distal end ofthe catheter assembly away from the first longitudinal axis. With thecollar in the distal position, the base may be rotatable relative to thecollar and the collar may be nonrotatable relative to the knob, so thatrotation of the knob about the second longitudinal axis results inrotation of the catheter assembly about the second longitudinal axis;and/or

the second longitudinal axis may be laterally offset from the firstlongitudinal axis in a direction transverse to the first longitudinalaxis; and/or

the collar and the knob each may have complementary serrations therein,and when the collar is in the distal position, the serrations of thecollar may be engaged with the serrations of the knob; and/or

the collar and the base each may have complementary serrations therein,and when the collar is in the proximal position, the serrations of thecollar may be engaged with the serrations of the base; and/or

the collar and the axial shaft each may have complementary serrationstherein, and the serrations of the collar may be permanently engagedwith the serrations of the axial shaft; and/or

the range of motion of the collar along the second longitudinal axis maybe distally limited by interference between the collar and the knob, andmay be proximally limited by interference between the collar and thebase; and/or

the nose, the screw, the knob, the collar, and the base each may extendcompletely circumferentially around a respective longitudinal portion ofthe axial shaft; and/or a lumen may extend at least partially throughthe axial shaft along the second longitudinal axis, the catheterassembly and the lumen of the axial shaft together being configured toreceive a mapping wire therethrough.

Also described herein are multiple embodiments of an operating handleconfigured to be coupled to a catheter assembly. The operating handlemay include a nose configured to be affixed to a proximal end of thecatheter assembly, an axial shaft having a distal end affixed to thenose, a proximal end, and a longitudinal axis, a base translationallyfixed to the proximal end of the axial shaft, a screw having externalthreads and a non-circular lumen, a knob having internal threads engagedwith the external threads of the screw, and a collar extending at leastpartially around the axial shaft in a circumferential direction. Theaxial shaft may extend through the non-circular lumen so that the screwis translatable along the axial shaft and nonrotatable relative to theaxial shaft. The knob may be translationally fixed to the nose.

The collar may be rotationally fixed to the nose, the axial shaft, andthe screw. The collar may be translatable between a proximal positionand a distal position. With the collar in the proximal position, theknob may be rotatable relative to the collar and the collar may benonrotatable relative to the base, so that rotation of the knob aboutthe longitudinal axis results in translation of the screw along theaxial shaft. With the collar in the distal position, the base may berotatable relative to the collar and the collar may be nonrotatablerelative to the knob, so that rotation of the knob about thelongitudinal axis results in rotation of the nose, the axial shaft, thescrew, and the collar relative to the base; and/or

the collar and the knob each may have complementary serrations therein,and when the collar is in the distal position, the serrations of thecollar may be engaged with the serrations of the knob; and/or

the collar and the base each may have complementary serrations therein,and when the collar is in the proximal position, the serrations of thecollar may be engaged with the serrations of the base; and/or

the collar and the axial shaft each may have complementary serrationstherein, and the serrations of the collar may be permanently engagedwith the serrations of the axial shaft; and/or

the range of motion of the collar along the longitudinal axis may bedistally limited by interference between the collar and the knob, andmay be proximally limited by interference between the collar and thebase; and/or

the nose, the screw, the knob, the collar, and the base each may extendcompletely circumferentially around a respective longitudinal portion ofthe axial shaft.

Further described herein are multiple embodiments of a method of movinga catheter assembly with an operating handle. The method may includeproviding the catheter assembly and the operating handle. The operatinghandle may have a nose affixed to a proximal end of the catheterassembly, an axial shaft having a distal end affixed to the nose, a basetranslationally fixed to a proximal end of the axial shaft, a screwhaving external threads and a non-circular lumen, the axial shaftextending through the non-circular lumen, a pull wire extending from thescrew to a distal end of the catheter assembly, a knob having internalthreads engaged with the external threads of the screw, and a collarextending at least partially around the axial shaft in a circumferentialdirection.

The method may include moving the collar to a distal position relativeto the base. The method may include, while the collar is in the distalposition, rotating the knob in a first direction to rotate the catheterassembly, the nose, the axial shaft, the screw, and the collar relativeto the base. The method may include moving the collar to a proximalposition. The method may include, while the collar is in the proximalposition, rotating the knob in the first direction to pull the pull wirein a proximal direction, thereby deflecting the distal end of thecatheter assembly away from a longitudinal axis of the catheterassembly; and/or

the collar and the knob each may have complementary serrations therein,and moving the collar to the distal position may engage the serrationsof the collar with the serrations of the knob to rotationally lock thecollar to the knob; and/or

the collar and the base each may have complementary serrations therein,and moving the collar to the proximal position may engage the serrationsof the collar with the serrations of the base to rotationally lock thecollar to the base; and/or

the collar and the axial shaft each may have complementary serrationstherein, the serrations of the collar being permanently engaged with theserrations of the axial shaft so that the collar is rotationally lockedto the axial shaft; and/or

when the collar is moved to the distal position, the collar may bedistally limited by interference between the collar and the knob, andwhen the collar is moved to the proximal position, the collar may beproximally limited by interference between the collar and the base;and/or

the nose, the screw, the knob, the collar, and the base each may extendcompletely circumferentially around a respective longitudinal portion ofthe axial shaft.

1. A delivery device for an implantable medical device, the deliverydevice comprising: a catheter assembly having a proximal end, a distalend, and a compartment at the distal end for retaining the implantablemedical device, the catheter assembly extending along a firstlongitudinal axis, the catheter assembly having a pull wire extendingtherethrough, a distal end of the pull wire being affixed to the distalend of the catheter assembly; and an operating handle extending along asecond longitudinal axis, the operating handle including: a nose affixedto a proximal end of the catheter assembly; an axial shaft having adistal end affixed to the nose and a proximal end, the axial shaftextending along the second longitudinal axis; a base translationallyfixed to the axial shaft; a screw having external threads and anon-circular lumen, the axial shaft extending through the non-circularlumen so that the screw is translatable along the axial shaft andnonrotatable relative to the axial shaft, a proximal end of the pullwire being operably connected to the screw; a knob having internalthreads engaged with the external threads of the screw, the knob beingtranslationally fixed to the nose; and a collar extending at leastpartially around the axial shaft in a circumferential direction, thecollar being rotationally fixed to the nose, the axial shaft, and thescrew, the collar being translatable between a proximal position and adistal position; with the collar in the proximal position, the knobbeing rotatable relative to the collar and the collar being nonrotatablerelative to the base, so that rotation of the knob about the secondlongitudinal axis results in deflection of the distal end of thecatheter assembly away from the first longitudinal axis; and with thecollar in the distal position, the base being rotatable relative to thecollar and the collar being nonrotatable relative to the knob, so thatrotation of the knob about the second longitudinal axis results inrotation of the catheter assembly about the second longitudinal axis. 2.The delivery device of claim 1, wherein the second longitudinal axis islaterally offset from the first longitudinal axis in a directiontransverse to the first longitudinal axis.
 3. The delivery device ofclaim 1, wherein the collar and the knob each have complementaryserrations therein, and when the collar is in the distal position, theserrations of the collar are engaged with the serrations of the knob. 4.The delivery device of claim 1, wherein the collar and the base eachhave complementary serrations therein, and when the collar is in theproximal position, the serrations of the collar are engaged with theserrations of the base.
 5. The delivery device of claim 1, wherein thecollar and the axial shaft each have complementary serrations therein,and the serrations of the collar are engaged with the serrations of theaxial shaft when the collar is in the proximal position and when thecollar is in the distal position.
 6. The delivery device of claim 1,wherein a range of motion of the collar along the second longitudinalaxis is distally limited by interference between the collar and theknob, and is proximally limited by interference between the collar andthe base.
 7. The delivery device of claim 1, wherein the nose, thescrew, the knob, the collar, and the base each extend completelycircumferentially around a respective longitudinal portion of the axialshaft.
 8. The delivery device of claim 1, wherein a lumen extends atleast partially through the axial shaft along the second longitudinalaxis, the catheter assembly and the lumen of the axial shaft togetherbeing configured to receive a mapping wire therethrough.
 9. The deliverydevice of claim 1, wherein the proximal end of the pull wire is affixedto the screw.
 10. The delivery device of claim 9, wherein the proximalend of the pull wire is affixed to an insert, the insert being removablyengaged with a recess extending into a proximal end of the screw. 11.The delivery device of claim 10, wherein the screw includes a boreextending axially through the screw to the recess, the bore sized andshaped to receive the pull wire therethrough.
 12. The delivery device ofclaim 1, wherein the catheter assembly includes a base segment, and thedistal end of the catheter assembly includes a first segment positioneddistal to the base segment, and a second segment positioned distal tothe first segment, the base segment and the first segment beingseparated by a first weakened portion, and the first segment and thesecond segment being separated by a second weakened portion.
 13. Thedelivery device of claim 12, wherein the first and second weakenedportions are each less resistant to bending than the base segment, thefirst segment, and the second segment.
 14. The delivery device of claim12, wherein the first and second weakened portions are each biasedtowards a straight position in collinear alignment with the basesegment, such that when tension on the pull wire is released, the firstand second segments tend to return to the straight position in collinearalignment with the base segment.
 15. The delivery device of claim 14,wherein the first and second weakened portions each comprise a shapememory metal.
 16. The delivery device of claim 12, wherein when thecatheter assembly is at a minimum amount of deflection, the basesegment, first segment, and second segment are all collinear.
 17. Thedelivery device of claim 16, wherein when the catheter assembly is at amaximum amount of deflection, the first segment is substantiallyperpendicular to the base segment, and the second segment issubstantially perpendicular to the base segment and substantiallyparallel to the base segment, such that the base segment, first segment,and second segment form a “C”-shape.
 18. The delivery device of claim 1,wherein in an operative condition of the delivery device, theimplantable medical device is retained within the compartment at thedistal end of the catheter assembly, the implantable medical devicebeing a lead of an energy delivery device.
 19. The delivery device ofclaim 18, wherein the lead includes a helical screw-in anchor at adistal end thereof.
 20. The delivery device of claim 18, wherein, whenthe collar in the distal position, rotation of the knob about the secondlongitudinal axis results in rotation of the helical screw-in anchor ofthe lead.